Genito-Urinary Disease Site

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BLC3 (SWOG S1602)A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naive High-grade Non-muscle Invasive Bladder Cancer
A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naive High-grade Non-muscle Invasive Bladder Cancer

Complexity Level: 2

NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Planned

Chair: (Canada) Dr. Peter Black, Clinical Research Unit at Vancouver Coastal, (604) 875-5003


Planned
I234Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol
Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol

Complexity Level: 1

Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients must consent to undergo genomic screening. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed.

Objectives: Primary Objective - To centrally genotype cfDNA from patients with mCRPC progressing after a "next-generation" AR-pathway inhibitor in order to facilitate accrual to targeted therapy trials and then to assess the clinical benefit rate (CBR), of each Study Drug. Secondary Objectives - To determine the effect of each Study Drug on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of each Study Drug in mCRPC patients. Tertiary Objectives - To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Planned
I234AA Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastiatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
A Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastiatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients without history of hypersensitivity to AZD1775 or any of its excipients or who have not received treatment with drugs with a similar mechanism of action. Patients witout any factors that increase the risk of QTc prolongation or risk of arrhythmic events or mean resting corrected QT interval (QTc) <= 470 msec. Patients on drugs with a narrow therapeutic index which are substrates of BRCP, PGP, CYP2C19 or CYP1A2, inhibitors of PGP, and which cannot be discontinued or changed to alternative drugs are not eligible.

Objectives: To determine the effect of AZD1775 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of AZD1775 in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Michael Kolinsky, Cross Cancer Institute, (780) 432-8762


Planned
I234BA Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234.Men of childbearing potential must have agreed to use a highly effective contraceptive method during Study Drug treatment and for 6 months after stopping treatment and should not father a child or donate sperm during this period. Patients with significantly abnormal liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis are not eligible. Patients in whom strong inducers or inhibitors of CYP3A4 and strong inhibitors of CYP1A2 cannot be discontinued within 2 weeks before the first dose of savolitinib (3 weeks for St John's Wort) are not eligible..

Objectives: To determine the effect of savolitinib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of savolitinib in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Som Mukherjee, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Planned
I234CA Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234
A Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Serum potassium within normal limits. Prior abiraterone acetate or enzalutamide but not both. No prior cytotoxic systemic chemotherapy in the CRPC setting.

Objectives: To determine the effect of darolutamide on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of darolutamide in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Michael Ong, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75051


Planned
PNC1 (ECOG-ACRIN EA8134)InPACT: International Penile Advanced Cancer Trial
InPACT: International Penile Advanced Cancer Trial

Complexity Level: 2

NCT Registration ID (from clinicaltrials.gov): NCT02305654
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Planned

Chair: (Canada) Dr. Juanita Crook, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 3979


Planned
PRC5 (ECOG-ACRIN EA8161)Early Intervention after Radical Prostatectomy with Enzalutamide versus Androgen Deprivation Therapy in Men at Highest Risk of Metastasis by Genomic Stratification (ERADICATE)
Early Intervention after Radical Prostatectomy with Enzalutamide versus Androgen Deprivation Therapy in Men at Highest Risk of Metastasis by Genomic Stratification (ERADICATE)

Complexity Level: 2

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Planned

Planned
REC4 (ECOG-ACRIN EA8143)A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Complexity Level: 2

NCT Registration ID (from clinicaltrials.gov): NCT03055013
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Planned

Chair: (Canada) Dr. Anil Kapoor, St. Joseph's Healthcare Charlton Campus, (905) 522-6536, (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, (403) 521-3166


Planned
BLC4 (SWOG S1605)Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Complexity Level: 2

Eligibility: Patients with histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration. The carcinoma must be Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade. Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible. Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of carefor these patients. The reason for patients not to undergo cystectomy will be clearly documented.

Objectives: Complete response at 25 weeks after registration for those with a CIS component; event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS)treated with atezolizumab. To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1). Progression-free survival, cystectomy-free survival,bladder cancer specific survival, overall survival in all patients.

NCT Registration ID (from clinicaltrials.gov): NCT02844816
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: April 07, 2017

Chair: (Canada) Dr. Peter Black, Clinical Research Unit at Vancouver Coastal, (604) 875-5003, (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246


Open to Accrual
I223A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer
A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer

Complexity Level: 1

Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients will be pre-screened for CCDN1 amplification and RB1 status. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed. Potent/strong CYP3A inhibitors/inducers not allowed.

Objectives: PRIMARY - To assess the clinical benefit rate (CBR) of palbociclib in patients with metastatic, castration-resistant prostate cancer (mCRPC). SECONDARY - (1) To determine the effect of palbociclib on PSA decline and time to PSA progression; (2) To determine objective response as determined by RECIST 1.1 criteria; (3) To evaluate the safety and toxicity profile of palbociclib in mCRPC patients. EXPLORATORY - (1) To determine whether CCND1 gain/amplification in plasma cell-free DNA (cfDNA) (+/-RB1 wild type) is predictive of CBR to palbociclib; (2) To evaluate gene copy number variation and mutation profile of cfDNA in patients with mCRPC before and after treatment with palbociclib; (3) To identify potential predictive and prognostic blood-based RNA markers.

NCT Registration ID (from clinicaltrials.gov): NCT02905318
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: February 09, 2017

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Open to Accrual
PR19A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

Complexity Level: 1

Eligibility: Patients enrolled in this study must have histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months and have low- (clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL) or intermediate-risk (clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and < 50% of positive cores) prostate cancer.

Objectives: Primary objective: prostate cancer control as defined by 48 month PSA values Secondary objectives: Disease-free survival, acute and long term toxicity and safety, Quality of Life (QOL) of the patient and their spouse/partner, resource utilization and economic indices of treatment administration. Tertiary objective: To establish a comprehensive tumour bank linked to a clinical database for the further study of predictive and prognostic biomarkers in prostate cancer.

NCT Registration ID (from clinicaltrials.gov): NCT02960087
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: November 04, 2016

Chair: (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, (418) 691-5264, (Canada) Dr. Gerard Morton, Odette Cancer Centre, (416) 480-6165


Open to Accrual
REC3 (SWOG S1500)A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)

Complexity Level: 2

Eligibility: Patients must have histologically or cytologically confirmed papillary renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection. They must also have measurable disease (RECIST), they may have received prior therapy (up to one prior systemic therapy for advanced or metastatic renal cell carcinoma or prior radiation therapy), have a Zubrod PS of 0-1, have adequate hematologic and hepatic function, and be 18 years of age or older. Patients must have tissue available and be willing to submit for central pathologic review.

Objectives: Primary Objective: To compare progression-free survival (PFS) in patients with mPRCC treated with sunitinib to PFS in patients with mPRCC treated with MET kinase inhibitors. Secondary Objectives: a. To compare RECIST response rate (RR; defined as the combined rate of confirmed and unconfirmed PR and confirmed and unconfirmed CR) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors. b. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors. c. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC. Translational Objectives: To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors

NCT Registration ID (from clinicaltrials.gov): NCT02761057
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: July 27, 2016

Chair: (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, (403) 521-3166


Open to Accrual
I232A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

Complexity Level: 2

Eligibility: Patients with histologically confirmed adenocarcinoma of the prostate that is castrate resistant. Must have disease progression either PSA, objective or both as well as surgical or medical castration with testosterone levels <50mg/dL. An available tissue block from primary or metastatic tumour as well as accessible disease suitable for fresh biopsy and consent to biopsy prior to treatment is required. Patients must have measurable disease per RECIST 1.1. Patients may have received prior treatment with docetaxel chemotherapy, tyrosine kinase or other targeted agents. Failure/progression on abiraterone and/or enzalutamide is required. Antiandrogens must have been discontinued for < 4 weeks prior to study entry (6 weeks for bicalutamide). No prior immunotherapy or vaccines, treatment with oncolytics viruses is permissible. No prior history of immunodeficiency, or use or immunosuppressive agents within 28 days of randomization.

Objectives: Primary - To determine the objective response rate (RECIST 1.1 and irRECIST) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with durvalumab alone or in combination with tremelimumab. Secondary - To determine the prostate-specific antigen (PSA) response rate as time to PSA progression; To evaluate time to objective disease progression; To evaluate the toxicity and tolerability of durvalumab alone or in combination with tremelimumab. Exploratory - To explore the utility of tissue and blood based biomarkers to select patients for treatment with durvalumab alone or in combination with tremelimumab.

NCT Registration ID (from clinicaltrials.gov): NCT02788773
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: On Hold
Activation Date: August 18, 2016

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261, (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


On Hold
BL12A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen
A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen

Complexity Level: 2

Eligibility: Patients enrolled in this study must have histologically or cytologically confirmed diagnosis of transitional cell carcinoma of the urinary tract (bladder, urethra, ureter, renal pelvis) and metastatic or locally advanced inoperable disease extent (T4, N2, N3 or M1 disease).

Objectives: Primary Objective: progression free survival (PFS) Secondary Objectives: objective response rates (ORR), clinical benefit rate (CBR), time to response and response duration, safety, QOL, and health analysis Exploratory Objectives: Correlative Biology, Health and Demographic Assessment

NCT Registration ID (from clinicaltrials.gov): NCT02033993
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: January 27, 2014 Closing Date: April 06, 2017

Chair: (Canada) Dr. Srikala Sridhar, University Health Network, (416) 946-4501 Ext. 2520


Closed to Accrual
BLC1 (SWOG S1011)A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer
A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer

Complexity Level: 2

Eligibility: Patients must have histologically-proven (T2, T3, or T4a) urothelial carcinoma of the bladder (UCB) that requires primary radical cystectomy for definitive treatment.

Objectives: Primary: To compare disease-free survival (DFS) in eligible patients treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Secondary: To compare overall survival (OS) between extended PLND versus standard pelvic lymphadenectomy. To evaluate operative time, whether nerve sparing was performed, morbidity and mortality, length of hospital stay, histology, lymph node counts density, adjuvant chemotherapy, and local and retroperitoneal soft tissue recurrence. Proximal extent of node dissection in those patients randomized to extended PLND will be evaluated as well. Translational Medicine Objectives: a. To bank paraffin embedded blocks or slides of the primary tumor, b. To determine the prognostic value of putative markers of the premetastatic niche, c. To evaluate if the prevalence of pre-metastatic niche is different between patients that received neoadjuvant chemotherapy and those who did not.

NCT Registration ID (from clinicaltrials.gov): NCT01224665
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 15, 2014 Closing Date: February 15, 2017

Chair: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246


Closed to Accrual
PR13 (MRC PR10)RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery.
RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery.

Complexity Level: 2

Eligibility: Men who have undergone radical prostatectomy for prostateic adenocarcinoma within 3 months. RT Timing Randomization: Post-opterative serum PSA less than 0.4 ng/mL. Uncertainty in the opinon of the physician and patient regarding the need for immediate post-operative RT. Hormone Duration Randomization: Post-opterative serum PSA less than 10 ng/mL. Patient is due to receive post-operative RT either adjuvant or salvage.

Objectives: Disease free survival; Freedom from treatment failure; Clinical progression-free survival; Overall survival; Non-protocol hormone therapy Quality of life; Treatment toxicity

NCT Registration ID (from clinicaltrials.gov): NCT00541047
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 27, 2007 Closing Date: December 30, 2016

Chair: (Canada) Dr. Charles Catton, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2121, (Canada) Dr. Fred Saad, Centre de Recherche du CHUM, (514) 890-8000 Ext. 27466


Closed to Accrual
PR15Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

Complexity Level: 1

Eligibility: . Histologically confirmed CaP . PSA < 20 ng /ml . TNM classification . T2b to T2c, GS < 8/10 or . T1c-T2a GS 7/10 or . T1c-T2a, GS less than or equal to 6/10, 10 less than or equal to PSA < 20 . Prostate volume less than or equal to 75 cc

Objectives: Primary: The primary objective of this feasibility study is to assess the ability of Canadian investigators from multiple institutions to randomize patients to curative intent IGRT or IGRT with HDR brachytherapy boost. Secondary: Acute GU and GI adverse events; Quality assurance; Treatment compliance

NCT Registration ID (from clinicaltrials.gov): NCT01982786
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: November 05, 2013 Closing Date: September 30, 2015

Chair: (Canada) Dr. Douglas Andrew Loblaw, Odette Cancer Centre, (416) 480-4806, (Canada) Dr. Gerard Morton, Odette Cancer Centre, (416) 480-6165, (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, (418) 691-5264


Closed to Accrual
PR17 (ANZUP 1304)Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

Complexity Level: 2

Eligibility: Men starting first line androgen deprivation therapy for metastatic adenocarcinoma of the prostate. Key eligibility criteria include metastatic prostate cancer, adequate organ function and ECOG performance status 0-2.

Objectives: Primary endpoint: Overall survival

NCT Registration ID (from clinicaltrials.gov): NCT02446405
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 02, 2015 Closing Date: March 24, 2017

Chair: (Canada) Dr. Scott North, Cross Cancer Institute, (780) 432-8762


Closed to Accrual
PRC3 (CALGB C90203)A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.
A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.

Complexity Level: 2

Eligibility: Patients with High-Risk, Clinically Localized Prostate Cancer.

Objectives: PSA Free Survival 3 Years Post Op; Compare 5-year bPFS, Disease Progresssion; Disease Free Survival and Overall Survival; Difference in Pathologic Stage; Safety and Tolerability; Correlative Studies: Diet and lifestyle; Frozen Tissue and Paraffin Blocks for Biomarker Analyses, Expression Profiling, chromosomal Gain or Loss Analysis

NCT Registration ID (from clinicaltrials.gov): NCT00430183
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 15, 2007 Closing Date: October 02, 2015

Chair: (Canada) Dr. Martin E. Gleave, Clinical Research Unit at Vancouver Coastal, (604) 875-4111


Closed to Accrual
PRC4 (ALLIANCE A031201)Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

Complexity Level: 2

Eligibility: Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.

Objectives: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer treated with either enzalutamide only or enzalutamide with abiraterone and prednisone. To assess the toxicity profile and compare safety by treatment arm, to assess and compare post-treatment PSA declines by treatment arm, to compare radiographic progression free survival and objective response rate by treatment arm, to test for radiographic progression free survival treatment interaction in predicting overall survival, to assess pre- and post-treatment measures of tumor burden and bone activity using PET/CT and bone scintigraphy and correlate these measures with overall survival, and to develop and validate prognostic and predictive models of overall survival.

NCT Registration ID (from clinicaltrials.gov): NCT01949337
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 27, 2014 Closing Date: August 31, 2016

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Closed to Accrual
REC2 (ECOG E2805)ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Complexity Level: 2

Eligibility: Patients with primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent.

Objectives: Primary: To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients receiving Sunitinib vs Sorafenib vs placebo after radical or partial nephrectomy. Secondary: To compare overall survival of patients randomized to each of the two regimens with placebo, to further define toxicity of prolonged administration of study agents and to collect biological specimens to assess their characteristics and associations.

NCT Registration ID (from clinicaltrials.gov): NCT00326898
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 14, 2006 Closing Date: September 02, 2010

Chair: (Canada) Dr. Lori Wood, QEII Health Sciences Centre, (902) 473-6106, (Canada) Dr. Michael A.S. Jewett, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2909


Closed to Accrual
BL1A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer
A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 20, 1979 Closing Date: September 01, 1980

Permanently Closed
BL10 (4B951)MVAC in Organ-Confined Bladder Cancer Based on p53 Status.
MVAC in Organ-Confined Bladder Cancer Based on p53 Status.

Eligibility: Patients who have undergone a radical cystectomy and bilateral pelvic lymphadenectomy

Objectives: To compare the recurrence free and overall survival of those patients with alterations in the p53 gene who are treated with MVAC to patients with tumours demonstrating p53 alterations who are observed. To compare the recurrence free and overall survival prospectively of patients with tumours demonstrating alterations in p53 who are observed to patients with no p53 alterations who are also observed. To examine the expression of p53 and other genes, particularly RB, p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy. To study the association of p53 mutational gene status with p53 proteinexpression by IHC, outcome (recurrence-free and overall survival).

NCT Registration ID (from clinicaltrials.gov): NCT00005047
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: December 22, 2003 Closing Date: March 28, 2006

Chair: (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673


Permanently Closed
BL11A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder
A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder

Eligibility: Patients with high risk Ta, Tis or T1 superficial bladder cancer, who completed transurethral resection of all visible bladder lesions within 21 to 60 days prior to randomization, and without other evidence of metastasis.

Objectives: Comparisons of time to treatment failure, complete response rate for patients with carcinoma in situ (Tis) at randomization, time to recurrence, time to progression, overall survival, adverse event and safety, and quality of life. Evaluate prognostic significance of tumour marker expression on the primary tumour and impact of therapy on tumour marker expression.

NCT Registration ID (from clinicaltrials.gov): NCT00352079
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 12, 2006 Closing Date: December 04, 2008

Chair: (Canada) Dr. Louis Lacombe, CHUQ - Hotel Dieu de Quebec, (418) 691-5O50


Permanently Closed
BL2The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer
The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 18, 1981 Closing Date: October 15, 1982

Permanently Closed
BL3NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder
NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 03, 1985 Closing Date: April 19, 1989

Permanently Closed
BL4 (E5886)A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer
A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 30, 1986 Closing Date: May 15, 1989

Permanently Closed
BL5 (BA06)A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder
A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: March 02, 1990 Closing Date: June 01, 1995

Chair: (Canada) Dr. Mary Gospodarowicz, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4421


Permanently Closed
BL7 (30987)Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy
Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy

Eligibility: Patients with locally advanced and/or metastatic cell carcinoma of the urothelium who have not had prior systemic therapy. Patients must have histologically proven stage IV locally advanced disease (T4b, N0-N1) or metastatic ((N2N3 or M10 transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter and renal pelvis. Patients should not be suitable for surgery or radiation with curative intent. However, patients whose pre-chemotherapy sites of disease are restricted to the primary or regional lymph node sites and who have had a major response to chemotherapy will be evaluated for post-chemotherapy surgical resection of residual cancer if the tumour has become resectable at the end of chemotherapy.

Objectives: The primary objective of this trial is to compare two treatment groups, cisplatin/ gemcitabine and cisplatin/ gemcitabine/ paclitaxel, with respect to the duration of survival. Secondary objectives are to compare in the two treatment groups the: 1) duration of progression-free survival 2) response rates (RECIST) 3)duration of response. Also to compare and characterize the nature of the toxicity experienced in each arm.

NCT Registration ID (from clinicaltrials.gov): NCT00022191
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: December 11, 2001 Closing Date: June 01, 2004

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
BL8 (30994)Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.
Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.

Complexity Level: 2

Eligibility: Patients with histologically proven transitional cell carcinoma (TCC) of the bladder (pT2 incidental pT3 or pT4) and/or node positive (pN1-3) M0 TCC following radical cystectomy and lymphadenectomy. Lymph node dissection of 15 or more lymph nodes is recommended. Patients must be able to start chemotherapy within 90 days after surgery.

Objectives: To compare the survival of patients with T3-T4 or N+ bladder cancer after radical cystectomy when treated with immediate adjuvant chemotherapy versus chemotherapy at relapse; to compare the progression-free survival.

NCT Registration ID (from clinicaltrials.gov): NCT00028756
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: December 11, 2001 Closing Date: May 09, 2008

Chair: (Canada) Dr. Fred Saad, Centre de Recherche du CHUM, (514) 890-8000 Ext. 27466, (Canada) Dr. Lori Wood, QEII Health Sciences Centre, (902) 473-6106


Permanently Closed
I111A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer
A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 12, 1998 Closing Date: January 22, 1999

Permanently Closed
I119A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma
A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 16, 1999 Closing Date: March 21, 2000

Permanently Closed
I128NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy
NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 03, 1999 Closing Date: May 01, 2001

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
I140A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer
A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer

Eligibility: Prostate cancer patients with evidence of progression by rising PSA or progressive measurable disease on androgen ablative therapy; PSA > 20 ng/mL; chemo-naive; minimally symptomatic disease.

Objectives: To determine the efficacy, and toxicity of two different doses of ZD1839 (250 mg or 500 mg) in patients with hormone refractory prostate cancer. Objective response where applicable, PSA response and duration of these responses, will be measured.

NCT Registration ID (from clinicaltrials.gov): NCT00025116
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 24, 2001 Closing Date: April 25, 2002

Permanently Closed
I143A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma
A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Eligibility: Patients with recurrent or metastatic renal cell carcinoma. No prior chemotherapy or immunotherapy for advanced/recurrent disease. Clinically and/or radiologically documented unidimensionally measurable disease.

Objectives: To evaluate the efficacy and safety of MG98 when given as a 2-hour IV infusion twice weekly for 3 out or every 4 weeks in patients with advanced and/or metastatic renal cell carcinoma.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 2001 Closing Date: May 10, 2002

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
I153A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer

Eligibility: Histologically confirmed adenocarcinoma of the prostate. No prior treatment. Must be a potential candidate for radical prostatectomy. Minimum 2 positive biopsies and at least one of the following: clinical stage T3; serum PSA > 10 ng/ml; Gleason score 7-10 or Gleason score 6 and >= 3 positive biopsies

Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 administered days 1, 3, 5, 8, 15, 22 and 29 intravenously with neoadjuvant hormone therapy prior to radical prostatectomy. To determine the plasma pharmacokinetic profile To determine the tissue concentration of OGX-011 in radical prostatectomy specimens. To measure evidence of effect on clusterin expression in peripheral blood mononuclear cells and clusterin serum levels. To assess the effect of the combined hormone and OGX-011 therapy on com[plete response rates. To attempt to establish correlations between palsma and or prostate concentrations of OGX-011 with patient response or toxicity.

NCT Registration ID (from clinicaltrials.gov): NCT00054106
Participation: Limited to one centre: BCCA-Vancouver
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 06, 2002 Closing Date: May 05, 2004

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I161A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma
A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

Eligibility: Patients with histologically or cytologically documented renal cell cancer that is locally recurrent or metastatic. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. No prior systemic chemotherapy regimens. Previous interferon permitted > 3 months prior to study entry. No immunotherapy for advanced/recurrent disease. No gene therapy. Known HIV-positive patients are not permitted nor patients with known glucose-6 phosphate dehydrogenase deficiency.

Objectives: To assess the efficacy (objective response rate) of Triapine given as a 2-hour IV infusion for 4 consecutive days every other week to patients with recurrent/ metastatic renal cell cancer who have received no prior systemic therapy for recurrence. To determine adverse events and tolerability of Triapine in this patient population. To describe time to disease progression and overall patient survival.

NCT Registration ID (from clinicaltrials.gov): NCT00075660
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 16, 2004 Closing Date: April 05, 2005

Chair: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2399


Permanently Closed
I165A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.
A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.

Eligibility: Histologically or cytologically diagnosed prostate cancer with documented evidence of progression by rising PSA (>5 ng/mL at baseline). Patients must have metastatic or locally recurrent disease for which no curative therapy exists and for which systemic chemotherapy is indicated due to progression while receiving androgen ablative therapy. No prior chemotherapy except estramustine. Prior hormone therapy permitted but must be refractory and discontinued > 4 weeks (6 wks for bicalutamide). Prior radiation permitted if > 4 weeks. ECOG 0, 1, 2. Adequate organ function. No pre-existing neuropathy >= grade 2 or therapeutic anti-coagulation.

Objectives: To determine the efficacy, as measured by PSA response and duration of response, of weekly OGX-011 administered intravenously in combination with q 3 weekly docetaxel and prednisone, or docetaxel and prednisone in patients with HRPC. To determine objective response and duration in those with measurable disease at baseline. To determine tolerability and toxicity when given in this schedule. To measure evidence of OGX-011 and docetaxel or docetaxel effect on serum clusterin levels. To describe time to progression and overall patient survival for both cohorts.

NCT Registration ID (from clinicaltrials.gov): NCT00258388
Participation: Limited to selected centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 27, 2005 Closing Date: December 21, 2006

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I167Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer
Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer

Eligibility: Patients with histologically or cytologically diagnosed prostate cancer that is advanced and non-curable with standard therapy. PSA progression with PSA>10 ng/mL at study entry. Primary tumour available for immunohistochemistry. No prior chemotherapy. Minimally symptomatic disease.

Objectives: To determine PSA response rate. To determine objective response rate and duration of response as measured by RECIST. To determine the tolerability and toxicity of BAY 43-9006 given to this patient population. To describe time to treatment failure and overall patient survival. To correlate the relationship between tumour markers and patients with response and with non-progression.

NCT Registration ID (from clinicaltrials.gov): NCT00093457
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 21, 2004 Closing Date: December 20, 2005

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I195A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer
A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer

Complexity Level: 2

Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. Up to 1 prior chemotherapy regimen is permitted. ECOG 0 or 1. Adequate cardiac function and acceptable end-organ function.

Objectives: 1.1 The primary objective of this study is to determine the efficacy (as measured by PSA response and progression free survival) of SB939 when given orally every other day 3 times a week, in patients with castration resistant prostate cancer, who have received 0-1 prior chemotherapy regimens. 1.2 To determine objective response and response duration in patients with measurable disease at baseline. 1.3 To determine the tolerability and toxicity of SB939 in this population. 1.4 Enumeration of Circulating Tumour Cells (CTC) at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment) using two methodologies. 1.5 To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue. 1.6 To explore the utility of ERG and PTEN expression on circulating tumour cells as a potential prognostic and predictive marker for response to SB939. 1.7 To describe time to PSA and time to objective progression in patients treated with SB939.

NCT Registration ID (from clinicaltrials.gov): NCT01075308
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 2010 Closing Date: November 04, 2011

Chair: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707, (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I205A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).

Complexity Level: 2

Eligibility: Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration. Either:PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of >= 5 ng/ml and must be performed no longer than 7 days prior to trial registration.OR Radiological Progression. The PSA must be >=5 ng/ml at the time of study entry. ECOG performance of 0, 1 or 2; Age > 18 years of age. All patients must have formalin fixed paraffin embedded tissue. Presence of clinically and/or radiologically documented disease.

Objectives: To determine the efficacy of PX-866 when given orally daily in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease.To determine the tolerability and toxicity. of PX-866 in this population. To investigate additional potential measures of efficacy including: PSA response rate, Objective response rate, Change in circulating tumour cell number during treatment. To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue and baseline circulating tumour cells. In selected participating centres, to determine evidence of effect on PI3K activation pre- and post administration of PX-866 in platelets

NCT Registration ID (from clinicaltrials.gov): NCT01331083
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 2011 Closing Date: January 10, 2014

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746, (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Permanently Closed
I209A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer
A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer

Complexity Level: 2

Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Tumour block available. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. No prior chemotherapy for recurrent/metastatic disease. No prior docetaxel unless given adjuvantly and >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function.

Objectives: 1. To evaluate efficacy which will be based on the lack of disease progression measured at 12 weeks. 2a. To determine the tolerability and toxicity of Reolysin and docetaxel when given in combination. 2b. To investigate additional potential measures of efficacy including CTC status, CTC conversion rate, change in PSA levels, Objective response rate and effect of both treatments on overall survival. 2c. Explore potential molecular factors predictive of response in archival tumour and baseline CTCs.

NCT Registration ID (from clinicaltrials.gov): NCT01619813
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 11, 2012 Closing Date: September 25, 2015

Chair: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707


Permanently Closed
I24NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell
NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 06, 1985 Closing Date: November 26, 1986

Permanently Closed
I38NCIC CTG Phase II Study of TNF in Renal Cell
NCIC CTG Phase II Study of TNF in Renal Cell

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1988 Closing Date: September 01, 1989

Permanently Closed
I4NCIC CTG Phase II Study of Lonidamine in Hypernephroma
NCIC CTG Phase II Study of Lonidamine in Hypernephroma

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1982 Closing Date: May 05, 1984

Permanently Closed
I46NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma
NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 25, 1989 Closing Date: May 11, 1990

Permanently Closed
I49NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma
NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 19, 1990 Closing Date: November 30, 1990

Permanently Closed
I6NCIC CTG Phase II Study of Interferon in Renal Cell Cancer
NCIC CTG Phase II Study of Interferon in Renal Cell Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 01, 1983 Closing Date: September 20, 1984

Permanently Closed
I70NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma
NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 24, 1992 Closing Date: February 03, 1993

Permanently Closed
I88A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma
A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 03, 1995 Closing Date: April 29, 1997

Permanently Closed
I95NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract
NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 06, 1996 Closing Date: October 03, 1997

Permanently Closed
PR1Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate
Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1979 Closing Date: May 26, 1981

Permanently Closed
PR10 (Z0070)Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer
Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

Eligibility: Patients must have a PSA of < 10 ng/ml. Patients must have histologically proven clinical stage T1c (usually impalpable) or T2a (unilaterally abnormality, papable or visible on TRUS), N0, M0 adenocarcinoma of the prostate, diagnosed within 120 days prior to registration on this study. Note: bilateral palpable disease is not allowed.

Objectives: To ascertain whether patients assigned to receive brachytherapy have equal or better overall survival as compared to patients randomized to receive radical prostatectomy. To compare the two treatment arms with respect to: metastasis-free survival, the probability of survival without symptoms, side effects from the intervention and Quality of Life addressed in the companion study.

NCT Registration ID (from clinicaltrials.gov): NCT00023686
Participation: Limited to centres with a current CPA/FWA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 19, 2002 Closing Date: April 09, 2004

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 5259


Permanently Closed
PR10C (Z0071)Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy
Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy

Eligibility: Must be randomized to PR.10

Objectives: To obtain quality of life information.

NCT Registration ID (from clinicaltrials.gov): NCT00052481
Participation: Patients randomized to PR.10
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: September 19, 2003 Closing Date: April 09, 2004

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 5259


Permanently Closed
PR11A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)
A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)

Complexity Level: 2

Eligibility: Histologically confirmed adenocarcinoma of the prostate that is negative for metastasis. Patient is a suitable candidate for radical prostatectomy or radiotherapy. No previous treatment for prostate cancer for greater than 6 months. Patient has been classified as favourable risk as defined by the following: clinical stage T1b, T1c, T2a or T2b, surgical Gleason score <= 6, PSA <= 10.0 ng/ml. For more information, please view our Patient Educational Video at the following web link: http://smaug/trials/start/start.html

Objectives: To compare disease specific survival in patients with favourable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis to active surveillance and selective intervention based on pre-specified biochemical, histological or clinical criteria.

NCT Registration ID (from clinicaltrials.gov): NCT00499174
Participation: Not limited
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 15, 2007 Closing Date: May 13, 2011

Chair: (USA) Dr. Adam S. Kibel, Washington University School of Medicine, (314) 362-8295, (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673


Permanently Closed
PR12Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART)
Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART)

Eligibility: Patients with histologically proven, localized (NO, M0) adenocarcinoma of the prostate with adverse prognostic features which are considered to be high risk for recurrence based on the presence of at least one of the following features: T stage > or = to 3a, Gleason Score > or = 8 or presenting PSA>20

Objectives: The primary objective is to compare disease free survival rates in men treated with androgen suppression therapy and radiation therapy followed by androgen suppression therapy with or without neoadjuvant docetaxel. Secondary objectives include overall survival, degree of PSA suppression prior to radiation therapy and Quality of Life.

NCT Registration ID (from clinicaltrials.gov): NCT00651326
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 03, 2008 Closing Date: November 12, 2009

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746, (Canada) Dr. Michael McKenzie, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2380


Permanently Closed
PR2 (8794)Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy
Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 22, 1990 Closing Date: January 01, 1997

Chair: (Canada) Dr. Joseph Chin, London Health Sciences Centre, (519) 685-8451


Permanently Closed
PR3 (PR3)Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate
Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate

Eligibility: Patients with adenocarcinoma of the prostate who have performance status of 0-2, adequate blood counts and liver and kidney function, and no contraindication to pelvic radiotherapy.

Objectives: To evaluate any benefit from the addition of radiation therapy to the treatment of the patients with cancer of the prostate who are receiving hormonal therapy in terms of overall survival, time to progression, symptomatic local control, and quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00002633
Participation: Limited to North America centres with current CPA/FWA#; all MRC - UK centres.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 08, 1995 Closing Date: August 31, 2005

Chair: (USA) Dr. George Wilding, Univ. of WI Comprehensive Can Ctr., (608) 263-0209, (USA) Dr. Srinivasan Vijayakumar, The University of Chicago Medical Center, (312) 791-2514, (USA) Dr. Richard Whittington, Veteran's Hospital, (215) 823-5855, (Canada) Dr. Padraig Warde, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2122


Permanently Closed
PR5 (PR5)A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 14, 1995 Closing Date: September 15, 1998

Chair: (Canada) Dr. Mary Gospodarowicz, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4421, (Canada) Dr. William James Morris, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2673


Permanently Closed
PR6Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain
Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain

NCT Registration ID (from clinicaltrials.gov): NCT00003232
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 24, 1997 Closing Date: May 14, 2001

Permanently Closed
PR7 (PR7)A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

Complexity Level: 2

Eligibility: Patients who completed radiotherapy to the prostate more than a year ago and who have a rising PSA > 3 ng/ml and higher than the lowest level since the end of radiotherapy without other evidence of metastasis.

Objectives: Comparisons of overall survival, time to the development of hormone resistance, quality of life, serum cholesterol and HDL/LDL levels. Evaluate duration of treatment and non-treatment intervals, time to testosterone recovery and time to recovery of potency.

NCT Registration ID (from clinicaltrials.gov): NCT00003653
Participation: Limited to centres with current CPA #.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 05, 1999 Closing Date: November 30, 2005

Chair: (USA) Dr. Celestia S. Higano, University of Washington, (206) 548-4518, (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673, (UK) Dr. David Dearnaley, Royal Marsden Hospital, (20) 8661-3271, (USA) Dr. Eric Horwitz, Fox Chase Cancer Centre, (215) 728-2995, (Canada) Dr. Juanita Crook, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 3979


Permanently Closed
PR8 (SWOG S9346)Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.
Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.

Complexity Level: 2

Eligibility: Patients with histologically or cytologically confirmed adenocarcinoma of the prostate, clinical stage D2 as evidenced by soft tissue and/ or bony metastases.

Objectives: To compare survival and quality of life in patients randomized to either intermittent or continuous combined androgen deprivation therapy (CAD).

NCT Registration ID (from clinicaltrials.gov): NCT00002651
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 19, 1998 Closing Date: August 31, 2008

Permanently Closed
PR9 (P-0011)Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy
Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy

Eligibility: Patients will have pathologic stage T3N0M0 prostate cancer at high-risk for PSA relapse as determined by GS > 7 and one or more of the following: 1) preoperative PSA > 10 ng/ml; 2) positive surgical margins; 3) seminal vesicle invasion. If Gleason score < 7, then two or more of the above factors. Patients who have negative LN status by lymph node sampling or LN dissection will be eligible. If pathologic LN status is unknown, the risk of involvement must be less than 5 % as determined by the Roach formula.

Objectives: To test, in a randomized study, if the addition of androgen suppression to radiation therapy in patients with unfavorable pathologic stage pT3N0M0 prostate cancer leads to better outcome than each used separately. The endpoints will be overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure. To compare the qualitative and quantitative toxicities of patients with pT3N0M0 prostate cancer treated adjuvantly with androgen suppression and radiation therapy to that of adjuvant radiation therapy or androgen suppression alone.

NCT Registration ID (from clinicaltrials.gov): NCT00023829
Participation: Limited to centres with a current CPA/FWA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 25, 2004 Closing Date: May 07, 2004

Chair: (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673


Permanently Closed
PRC2 (CALGB C90202)A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

Complexity Level: 2

Eligibility: 1) Histologic documentation of prostate adenocarcinoma. 2) At least one bone metastasis by radiographic imaging 3) While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. 4) No prior treatement with bisphosphonates. 5) No prior treatment with radiation and hormones as sepcified in section 5.4 of the protocol. 6) ECOG (CTC) performance status 0-2. 7) Min. Age 18. 8) Baseline laboratory data should fall within protocol required limits.

Objectives: Primary objective: To determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. Secondary objective: To determine whether treatment with zoledronic acid will decrease the proportion of men with one or more vertebral fractures at two years compared to placebo in men receiving androgen deprivation therapy for metastatic prostate cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00079001
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 07, 2006 Closing Date: April 02, 2012

Chair: (Canada) Dr. Fred Saad, Centre de Recherche du CHUM, (514) 890-8000 Ext. 27466


Permanently Closed
PRP1A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia
A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia

Eligibility: Documented high grade prostatic intraepithelial neoplasia (HGPIN) confirmed by the central reference pathologist. Two prostate biopsies performed within 18 months of randomization with the most recent within 6 months of randomization. Both biopsies must be negative for invasive prostate cancer.

Objectives: To compare disease free survival, changes in serum PSA, oxidative biomarkers and hormone levels with nutrient supplement, containing vitamin E, selenium and soy protein, or placebo. To determine the association between prostate cancer development and exposure to various hypothesized risk factor for prostate cancer and to evaluate the safety of the treatment.

NCT Registration ID (from clinicaltrials.gov): NCT00064194
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 28, 2001 Closing Date: July 23, 2004

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 5259


Permanently Closed
PRP1BAn Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product
An Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product

Eligibility: Subjects who have met the eligibility criteria for and were previously enrolled in the NCIC CTG PRP.1 study: A double-blind, placebo-controlled, randomized study of combination vitamin E, selenium and soy protein product in subjects with high grade prostatic intraepithelial neoplasia.

Objectives: To determine if molecular, genetic and immunohistochemical markers are associated with progression from high grade PIN to cancer. To determine if molecular or immunohistochemistry changes can occur in PIN among men treated with combination vitamin E, selenium and soy compared to placebo. To determine if cancers that arise within the PRP.1 study differ in terms of their proliferative capacity as measured by nuclear factor kappa B, p27 and ki-67, and to bank biopsy material, serum and DNA for future studies.

Participation: Limited to subjects enrolled on the PRP.1 study.
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 29, 2005 Closing Date: April 17, 2009

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 5259


Permanently Closed
REC1 (CALGB C90206)A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer
A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer

Complexity Level: 2

Eligibility: Patients with advanced renal cell cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00072046
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: April 23, 2004 Closing Date: July 01, 2005

Permanently Closed